Significant advantages for first line treatment with TNF-alpha inhibitors in pediatric patients with inflammatory bowel disease - Data from the multicenter CEDATA-GPGE registry study

Merle Claßen; Jan de Laffolie; Martin Claßen; Alexander Schnell; Keywan Sohrabi; André Hoerning

doi:10.3389/fped.2022.903677

Significant advantages for first line treatment with TNF-alpha inhibitors in pediatric patients with inflammatory bowel disease - Data from the multicenter CEDATA-GPGE registry study

Front Pediatr. 2022 Jul 19:10:903677. doi: 10.3389/fped.2022.903677. eCollection 2022.

Authors

Merle Claßen¹, Jan de Laffolie², Martin Claßen³, Alexander Schnell¹, Keywan Sohrabi², André Hoerning¹

Affiliations

¹ Clinic for Children and Adolescent Medicine, Friedrich Alexander University Erlangen-Nuremberg, Erlangen, Germany.
² Abteilung für Allgemeine Pädiatrie und Neonatologie, Justus Liebig University Gießen, Gießen, Germany.
³ Klinik für Kinder- und Jugendmedizin, Klinikum Bremen-Mitte, Bremen, Germany.

Abstract

Background and aims: In recent years, biological agents, such as anti-TNF-α blockers, have been introduced and have shown efficacy in pediatric patients with inflammatory bowel disease (IBD). Here, the prescription mode differentiated into a first/second line application, and efficacy and side effects are evaluated beginning from 2004 until today.

Methods: Statistical analyses of the prospective and ongoing CEDATA multicenter registry data from the Society of Pediatric Gastroenterology and Nutrition (GPGE) were performed for patients receiving a biological agent at least once during the period from June 2004 until November 2020 (n = 487). The analyzed parameters were patient demographics, disease extent and behavior, prior or concurrent therapies, duration and outcome of biological therapy, disease-associated complications, drug-related complications, laboratory parameters and treatment response as determined by the Physician's Global Assessment.

Results: Crohn's disease (CD) was present in 71.5% of patients, and 52% were boys. Patients showed high disease activity when receiving a first-line TNF-α blocker. After 2016, patients who failed to respond to anti-TNF-α induction therapy were treated with off-label biologics (vedolizumab 4.3% and ustekinumab 2.1%). Propensity score matching indicated that patients with CD and higher disease activity benefitted significantly more from early anti-TNF-α therapy. This assessment was based on a clinical evaluation and lab parameters related to inflammation compared to delayed second-line treatment. Additionally, first-line treatment resulted in less treatment failure and fewer extraintestinal manifestations during TNF-α blockade.

Conclusion: First-line treatment with anti-TNF-α drugs is effective and safe. An earlier start significantly reduces the risk of treatment failure and is associated with fewer extraintestinal manifestations during longitudinal follow-up.

Keywords: Crohn’s disease; anti-TNF-α inhibitor therapy; first-line therapy; pediatric inflammatory bowel disease (IBD); ulcerative colitis.